MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. BIOPSY FORCEPS

Model Number	FB-19K-1
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During inspection and testing, foreign matter was found on the arms of the cups (the linkage mechanism at the distal end) of the forceps.A review of the device history record found no deviations that could have caused or contributed to the foreign material being adhered.There were no anomalies noted in the operation or appearance of the tip.Based on the results of the legal manufacturer's investigation, it is likely the adhesion of foreign material is due to insufficient cleaning, or that it has not been sufficiently cleaned due to the passage of time after use.However, a definitive root cause of the reported issue could not be identified.The device's instruction manual provides the following warning, which may help to prevent the issue: "reprocess the instrument immediately after use by immersing it in a neutral, low-foaming, medical-grade detergent solution, then following the cleaning and sterilization procedures in this chapter.Failure to reprocess the instrument immediately after use, or using another type of detergent may cause corrosion at the instrument¿s distal end.This could cause components to fall off during use and may interfere with operation of the cups"."when inserting the instrument into the endoscope, hold it close to the biopsy valve or t-plug and keep it as straight as possible relative to the biopsy valve or t-plug.Otherwise, the insertion portion could be damaged".Olympus will continue to monitor field performance for this device.The report of there being a catch when operating the slider to open and close the cup was confirmed.There was a feeling of the forceps being caught when opening.After lubricant was applied, the cup opened and closed smoothly.Per the legal manufacturer, this device defect has no potential to cause or contribute to death or serious injury if the malfunction were to recur.
Event or Problem Description
The customer reported that, during preparation for use, there was a catch when the slider was moved back and forth during the pre-case inspection.The cup opened and closed, but there was a catch.The procedure was completed with another similar device.The subject device was sent to an olympus service center for evaluation.During inspection and testing, foreign matter was found on the forceps.This report is being submitted for the malfunction found during evaluation (foreign material).There was no harm or user injury reported due to the event.

• Brand Name: BIOPSY FORCEPS
• Common Device Name: BIOPSY FORCEPS
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14690003
• Report Number: 8010047-2022-10022
• Device Sequence Number: 15112595
• Product Code: EOQ
• UDI-Device Identifier: 04953170029608
• UDI-Public: 04953170029608
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K962555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FB-19K-1
• Device Lot Number: K1Y17-1757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown